Suicidal Ideation and BehaviorsV-BCBTNCT07395817
Video Conference-Based Brief Cognitive Behavioral Therapy for Suicidal High-Risk Outpatients With Mood Disorders
A study testing Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT) and Treatment as Usual (TAU) in people with Suicidal Ideation and Behaviors and Suicide Attempt, run by Hyung Keun Park at 1 site in South Korea.
Trial summary
This pilot randomized controlled trial aims to evaluate the feasibility, acceptability, and preliminary effectiveness of videoconference-based brief cognitive behavioral therapy (V-BCBT) for adult outpatients with mood disorders who are at high risk for suicide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideation and Behaviors, Suicide Attempt, Cognitive Behavioral Therapy
- What is being tested?
- Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT) and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High suicide risk, defined as either (a) a suicide attempt within the past 1 month or (b) Beck Scale for Suicide Ideation (SSI) ≥ 5.
- Aged 18 years or older.
- Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of a depressive disorder or bipolar and related disorder, confirmed at screening using the Mini International Neuropsychiatric Interview (M.I.N.I.).
- Able to read and write Korean without difficulty.
- Has access to a device (e.g., computer, tablet, or smartphone) and internet connectivity to participate in remote intervention.
- Able to understand the study, voluntarily provide written informed consent, and agree to comply with study procedures/precautions.
Who cannot join
- Currently in an activated manic state with psychotic symptoms, or has a severe psychiatric disorder (e.g., schizophrenia spectrum disorder), or a clinically significant neurological disorder, brain injury, intellectual disability, or any other medical condition that would prevent study participation.
- Has received psychotherapy within 3 months prior to screening (e.g., CBT, interpersonal psychotherapy, psychodynamic psychotherapy, or psychoanalysis).
- Is in an acute suicidal crisis requiring immediate inpatient hospitalization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Preliminary Effectiveness of Video Conference-Based Brief Cognitive Behavioral Therapy (V-BCBT) for Outpatients With Mood Disorders at High Risk for Suicide: A Pilot Randomized Controlled Trial
This pilot randomized controlled trial aims to evaluate the feasibility, acceptability, and preliminary effectiveness of videoconference-based brief cognitive behavioral therapy (V-BCBT) for adult outpatients with mood disorders who are at high risk for suicide. Eligible participants will be randomized (1:1) to either V-BCBT + treatment as usual (TAU) or TAU alone. V-BCBT consists of eight structured videoconference sessions (approximately 50-60 minutes each, twice weekly for 4 weeks) focusing on crisis management (for example, understanding the "suicide mode," developing a crisis response plan, strengthening reasons for living), cognitive and behavioral coping skills (for example, relaxation, behavioral activation, cognitive restructuring, mindfulness), and relapse prevention (for example, coping rehearsal and a relapse prevention plan).
- Being tested
- Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT), Treatment as Usual (TAU)
- Keywords
- Suicidal Ideation and Behaviors, Suicide Attempt, Cognitive Behavioral Therapy for Suicidality
- Medical subject headings
- Suicidal Ideation, Behavior, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT)Behavioural
Behavioral: V-BCBT is a brief, structured cognitive behavioral therapy (CBT) program delivered via videoconference for suicidal high-risk outpatients with mood disorders. It aims to reduce post-treatment and follow-up suicide risk by improving crisis coping/self-regulation, strengthening reasons for living, and shifting maladaptive "suicide mode" responses to adaptive alternatives. It includes 8 individual sessions (approximately 50 minutes) in three phases: (1) Crisis management (1-2): alliance, psychoeducation, crisis response plan (warning signs, coping, supports/resources), hope kit, and means safety; (2) Skills (3-6): relaxation, sleep regulation, behavioral activation/values goals, cognitive restructuring, mindfulness; (3) Relapse prevention (7-8): skills review, coping rehearsal, and a relapse prevention plan (update crisis plan). Sessions include practice and homework.
Other: TAU is routine outpatient care as indicated (e.g., medication and supportive psychotherapy).
Treatment as Usual (TAU)Other
Treatment as Usual (TAU) refers to routine outpatient care provided as clinically indicated, including medication treatment and supportive psychotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT) + Treatment as Usual (TAU) | Experimental | Participants in this arm will receive Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT) in addition to Treatment as Usual (TAU) provided in the outpatient setting. After randomization, they will complete 8 individual videoconference sessions of V-BCBT (approximately 50 minutes per session, twice weekly for 4 weeks), while continuing to receive routine outpatient care. TAU may include pharmacotherapy and supportive psychotherapy as typically provided in outpatient psychiatric services. Receives: Behavioral: Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT); Other: Treatment as Usual (TAU) |
| Treatment as Usual (TAU) only | Active comparator | Participants in this arm will receive Treatment as Usual (TAU) only through outpatient psychiatric services. TAU is delivered according to clinical need and may include pharmacotherapy and supportive psychotherapy as routinely provided. Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Suicide Attempts from Baseline to 3 Months After Treatment Completion
The number of suicide attempts will be assessed at five time points (baseline, post-treatment, and monthly during the 3-month follow-up) using the Columbia-Suicide Severity Rating Scale (C-SSRS), administered via in-person or telephone interview. Data will be cross-checked against available medical records as applicable.
Measured: Baseline: within 7 days before treatment start; Post-treatment: within 7 days after treatment completion; Follow-up assessments: at 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.
Time to First Suicide Attempt After Treatment Completion
The number of days from treatment completion (end of Videoconference-Based Brief Cognitive Behavioral Therapy) to the first reported suicide attempt, assessed through monthly follow-up period (for example, using the Columbia-Suicide Severity Rating Scale, administered in person or by telephone).
Measured: 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.
Secondary outcomes (5)
Intensity of suicidal ideation measured by Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal ideation intensity will be assessed using the Intensity of Ideation items of the C-SSRS (frequency, duration, controllability, deterrents, and reasons for ideation), each scored from 0 to 5. Higher scores indicate greater ideation intensity.
Measured: Baseline: ≤7 days before treatment start; Post-treatment: ≤7 days after treatment completion; Follow-up assessments: 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.
Severity of suicidal ideation measured by Beck Scale for Suicide Ideation (SSI)
Suicidal ideation severity will be assessed using the Beck Scale for Suicide Ideation, a 19-item self-report questionnaire. Each item is scored from 0 to 2, producing a total score from 0 to 38. Higher scores indicate greater severity of suicidal ideation.
Measured: Baseline: ≤7 days before treatment start; Post-treatment: ≤7 days after treatment completion; Follow-up assessments: 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.
Change in depressive symptoms measured by Hamilton Depression Rating Scale (HAM-D-17)
Depressive symptom severity will be assessed at five time points using the 17-item Hamilton Depression Rating Scale. This clinician-administered semi-structured interview yields total scores ranging from 0 to 52, with higher scores indicating more severe depression.
Measured: Baseline: ≤7 days before treatment start; Post-treatment: ≤7 days after treatment completion; Follow-up assessments: 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.
Change in depressive symptoms measured by Beck Depression Inventory-II (BDI-II)
Depressive symptom severity will be assessed at five time points using the Beck Depression Inventory-II, a 21-item self-report questionnaire. Each item is scored from 0 to 3, yielding total scores from 0 to 63. Higher scores indicate greater symptom severity.
Measured: Baseline: ≤7 days before treatment start; Post-treatment: ≤7 days after treatment completion; Follow-up assessments: 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.
Change in hopelessness measured by the Beck Hopelessness Scale (BHS)
Change in the level of hopelessness will be assessed at five time points: baseline, post-treatment, and monthly for 3 months following treatment completion. Hopelessness will be measured using the Beck Hopelessness Scale (BHS), a 20-item self-report questionnaire designed to assess negative expectations about the future. Each item is scored dichotomously (True/False), with total scores ranging from 0 to 20. Higher scores indicate greater levels of hopelessness and have been associated with increased suicide risk.
Measured: Baseline: ≤7 days before treatment start; Post-treatment: ≤7 days after treatment completion; Follow-up assessments: 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start16 Mar 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal Ideation and BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyung Keun Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hyung Keun Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395817
- Sponsor's protocol ID
- 2026-0177
- Acronym
- V-BCBT
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Effectiveness of Video Conference-Based Brief Cognitive Behavioral Therapy (V-BCBT) for Outpatients With Mood Disorders at High Risk for Suicide: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07395817
- Acronym / sponsor ID
- V-BCBT / 2026-0177
- Keywords
- Suicidal Ideation and Behaviors, Suicide Attempt, Cognitive Behavioral Therapy for Suicidality
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hyung Keun ParkUniversity, hospital or other
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot randomized controlled trial aims to evaluate the feasibility, acceptability, and preliminary effectiveness of videoconference-based brief cognitive behavioral therapy (V-BCBT) for adult outpatients with mood disorders who are at high risk for suicide. Eligible participants will be randomized (1:1) to either V-BCBT + treatment as usual (TAU) or TAU alone. V-BCBT consists of eight structured videoconference sessions (approximately 50-60 minutes each, twice weekly for 4 weeks) focusing on crisis management (for example, understanding the "suicide mode," developing a crisis response plan, strengthening reasons for living), cognitive and behavioral coping skills (for example, relaxation, behavioral activation, cognitive restructuring, mindfulness), and relapse prevention (for example, coping rehearsal and a relapse prevention plan).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT) + Treatment as Usual (TAU) | Experimental | Behavioral: Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT), Other: Treatment as Usual (TAU)Participants in this arm will receive Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT) in addition to Treatment as Usual (TAU) provided in the outpatient setting. After randomization, they will complete 8 individual videoconference sessions of V-BCBT (approximately 50 minutes per session, twice weekly for 4 weeks), while continuing to receive routine outpatient care. TAU may include pharmacotherapy and supportive psychotherapy as typically provided in outpatient psychiatric services. |
| Treatment as Usual (TAU) only | Active comparator | Other: Treatment as Usual (TAU)Participants in this arm will receive Treatment as Usual (TAU) only through outpatient psychiatric services. TAU is delivered according to clinical need and may include pharmacotherapy and supportive psychotherapy as routinely provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- High suicide risk, defined as either (a) a suicide attempt within the past 1 month or (b) Beck Scale for Suicide Ideation (SSI) ≥ 5.
- Aged 18 years or older.
- Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of a depressive disorder or bipolar and related disorder, confirmed at screening using the Mini International Neuropsychiatric Interview (M.I.N.I.).
- Able to read and write Korean without difficulty.
- Has access to a device (e.g., computer, tablet, or smartphone) and internet connectivity to participate in remote intervention.
Key exclusion criteria (3 listed)
- Currently in an activated manic state with psychotic symptoms, or has a severe psychiatric disorder (e.g., schizophrenia spectrum disorder), or a clinically significant neurological disorder, brain injury, intellectual disability, or any other medical condition that would prevent study participation.
- Has received psychotherapy within 3 months prior to screening (e.g., CBT, interpersonal psychotherapy, psychodynamic psychotherapy, or psychoanalysis).
- Is in an acute suicidal crisis requiring immediate inpatient hospitalization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT)Behavioral: V-BCBT is a brief, structured cognitive behavioral therapy (CBT) program delivered via videoconference for suicidal high-risk outpatients with mood disorders. It aims to reduce post-treatment and follow-up suicide risk by improving crisis coping/self-regulation, strengthening reasons for living, and shifting maladaptive "suicide mode" responses to adaptive alternatives. It includes 8 individual sessions (approximately 50 minutes) in three phases: (1) Crisis management (1-2): alliance, psychoeducation, crisis response plan (warning signs, coping, supports/resources), hope kit, and means safety; (2) Skills (3-6): relaxation, sleep regulation, behavioral activation/values goals, cognitive restructuring, mindfulness; (3) Relapse prevention (7-8): skills review, coping rehearsal, and a relapse prevention plan (update crisis plan). Sessions include practice and homework. Other: TAU is routine outpatient care as indicated (e.g., medication and supportive psychotherapy). | Behavioural | Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT) + Treatment as Usual (TAU) |
| Treatment as Usual (TAU)Treatment as Usual (TAU) refers to routine outpatient care provided as clinically indicated, including medication treatment and supportive psychotherapy. | Other | Treatment as Usual (TAU) only, Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT) + Treatment as Usual (TAU) |
Primary outcome
Number of Suicide Attempts from Baseline to 3 Months After Treatment Completion
Time frame: Baseline: within 7 days before treatment start; Post-treatment: within 7 days after treatment completion; Follow-up assessments: at 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.
The number of suicide attempts will be assessed at five time points (baseline, post-treatment, and monthly during the 3-month follow-up) using the Columbia-Suicide Severity Rating Scale (C-SSRS), administered via in-person or telephone interview. Data will be cross-checked against available medical records as applicable.
Time to First Suicide Attempt After Treatment Completion
Time frame: 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.
The number of days from treatment completion (end of Videoconference-Based Brief Cognitive Behavioral Therapy) to the first reported suicide attempt, assessed through monthly follow-up period (for example, using the Columbia-Suicide Severity Rating Scale, administered in person or by telephone).
5 secondary outcomes
Intensity of suicidal ideation measured by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline: ≤7 days before treatment start; Post-treatment: ≤7 days after treatment completion; Follow-up assessments: 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.
Severity of suicidal ideation measured by Beck Scale for Suicide Ideation (SSI)
Time frame: Baseline: ≤7 days before treatment start; Post-treatment: ≤7 days after treatment completion; Follow-up assessments: 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.
Change in depressive symptoms measured by Hamilton Depression Rating Scale (HAM-D-17)
Time frame: Baseline: ≤7 days before treatment start; Post-treatment: ≤7 days after treatment completion; Follow-up assessments: 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.
Change in depressive symptoms measured by Beck Depression Inventory-II (BDI-II)
Time frame: Baseline: ≤7 days before treatment start; Post-treatment: ≤7 days after treatment completion; Follow-up assessments: 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.
Change in hopelessness measured by the Beck Hopelessness Scale (BHS)
Time frame: Baseline: ≤7 days before treatment start; Post-treatment: ≤7 days after treatment completion; Follow-up assessments: 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videoconference-Based Brief Cognitive Behavioral Therapy (V-BCBT) and Treatment as Usual (TAU) in people with Suicidal Ideation and Behaviors and Suicide Attempt, run by Hyung Keun Park at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Suicide Attempts from Baseline to 3 Months After Treatment Completion (time frame: Baseline: within 7 days before treatment start; Post-treatment: within 7 days after treatment completion; Follow-up assessments: at 1 month (±7 days), 2 months (±7 days), and 3 months (±7 days) after treatment completion.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.